Stress, PsychologicalSPANCT02694211
Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation
A study testing ProMES in people with Stress, Psychological, run by Karolinska Institutet.
Trial summary
The Stress prevention at work (SPA) project intends to evaluate the method named Productivity Measurement and Enhancement System (ProMES) as a stress preventive approach among health care employees. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- ProMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All employees (18-67 years) employed at the intervention and control primary care units, who were actually working at the time for this study
Who cannot join
- employees absent due to long-term illness,
- employees absent due to parental leave
- employees absent due to long-term studies
About this study
Official title: Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)
The Stress prevention at work (SPA) project intends to evaluate the method named Productivity Measurement and Enhancement System (ProMES) as a stress preventive approach among health care employees.
Read the detailed description
Stress-related illnesses are today together with musculoskeletal disorders the predominant cause of production loss and absenteeism. The risks of developing stress-related mental illness is today well established, however, it is less studied how this can be successfully treated or prevented in workplaces through interventions.
The SPA project intends to evaluate the method the Productivity Measurement and Enhancement System (ProMES). The method is mainly evaluated for production improvement, but there are indications that it also has stress-reducing effect on working groups. The method gives employees within health care opportunities to participate actively in productivity-enhancing measures. The employees, along with their immediate supervisors, identify and prioritize responsive and desirable results in all of the activities important dimensions. International studies have shown that participation (participation) has positive effects on employee performance and attitudes.
The aim of this study is to test whether efforts in targeting the organization and work environment can reduce stress and prevent stress-related ill health in the workplace. Primary outcomes of the study are tense work i.e. imbalance between demand and control and other primary indicators of stress, such as sleep and recovery.
The hypothesis in study 1 is that productivity enhancing workplace interventions based on a participative approach also increases employees' sense of control and control over their own work. This in turn means that the method also could be used to reduce the occurrence of tense work and thus affect / reduce the stress-related illness.
- Conditions
- Stress, Psychological
- Being tested
- ProMES
- Keywords
- work related stress
- Medical subject headings
- Stress, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProMESBehavioural
Productivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement. Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback
| Study group | Role | What they receive |
|---|---|---|
| Intervention group ProMES | Experimental | Productivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement. Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback Receives: Behavioral: ProMES |
| Control group | No intervention | No intervention, business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in job strain (a measure of the balance between job demand and job control)
QPSNordic questionnaire
Measured: baseline, 6-months, 12-months
Secondary outcomes (9)
Change in Effort-Reward Imbalance
Effort-Reward Imbalance Questionnaire
Measured: baseline, 6-months, 12-months
Change in experience of stress
Single item stress question from Elo, A-L., Leppänen, A., Lindström K., Ropponen, T. OSQ-Occupational Stress Questionnaire: user's instructions. Helsinki: Finnish Institute of Occupational health; 1992. Reviews 19.
Measured: baseline, 6-months, 12-months
change in sleep difficulties
Two single questions Reference: Åkerstedt, T., Knutsson, A., et al. 2002. Att predicera sömnstörning, insomningsrisk och mental trötthet - tre delstudier. Psykosocial belastning och riskfaktorer för hjärtkärlsjukdom. Arbete och Hälsa 2002:7. Westerholm, P. Stockholm, Arbetslivsinstitutet
Measured: baseline, 6-months, 12-months
change in Recovery
One single question. Reference: Aronsson, G. och Svensson, L. 1997. Nedvarvning, återhämtning och hälsa bland lärare i grund- och gymnasieskolan. Arbete och Hälsa 1997:21. Stockholm, Arbetslivsinstitutet.
Measured: baseline, 6-months, 12-months
change in depression
Hospital Anxiety and Depression Scale
Measured: baseline, 6-months, 12-months
change in Sick leave
One single question:How many working days during the last 7 days, have you been away from work because of sick leave?
Measured: baseline, 6-months, 12-months
change in General health
A question from General Health Questionnaire (WHO)
Measured: baseline, 6-months, 12-months
change in Productivity
Questions from "Measuring production loss due to health and work environment problems: construct validity and implications."(Report) Lohela Karlsson, Malin ; Hagberg, Jan ; Bjorklund, Christina ; Bergstrom, Gunnar ; Jensen, Irene Journal of Occupational and Environmental Medicine, Dec, 2013, Vol.55(12), p.1475(9). Karolinska institutet. Stockholm
Measured: baseline, 6-months, 12-months
change in Exhaustion
Oldenburg Burnout Inventory
Measured: baseline, 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Jensen, Karolinska Institutet
- Investigators
- Irene Jensen, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694211
- Sponsor's protocol ID
- 2012/2200-31/5
- Acronym
- SPA
- Status last verified
- Feb 2016
- First submitted
- 30 Sep 2014
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)
- ClinicalTrials.gov ID
- NCT02694211
- Acronym / sponsor ID
- SPA / 2012/2200-31/5
- Conditions
- Stress, Psychological
- Keywords
- work related stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Stress prevention at work (SPA) project intends to evaluate the method named Productivity Measurement and Enhancement System (ProMES) as a stress preventive approach among health care employees.
Detailed description
Stress-related illnesses are today together with musculoskeletal disorders the predominant cause of production loss and absenteeism. The risks of developing stress-related mental illness is today well established, however, it is less studied how this can be successfully treated or prevented in workplaces through interventions.
The SPA project intends to evaluate the method the Productivity Measurement and Enhancement System (ProMES). The method is mainly evaluated for production improvement, but there are indications that it also has stress-reducing effect on working groups. The method gives employees within health care opportunities to participate actively in productivity-enhancing measures. The employees, along with their immediate supervisors, identify and prioritize responsive and desirable results in all of the activities important dimensions. International studies have shown that participation (participation) has positive effects on employee performance and attitudes.
The aim of this study is to test whether efforts in targeting the organization and work environment can reduce stress and prevent stress-related ill health in the workplace. Primary outcomes of the study are tense work i.e. imbalance between demand and control and other primary indicators of stress, such as sleep and recovery.
The hypothesis in study 1 is that productivity enhancing workplace interventions based on a participative approach also increases employees' sense of control and control over their own work. This in turn means that the method also could be used to reduce the occurrence of tense work and thus affect / reduce the stress-related illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group ProMES | Experimental | Behavioral: ProMESProductivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement. Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback |
| Control group | No intervention | –No intervention, business as usual |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All employees (18-67 years) employed at the intervention and control primary care units, who were actually working at the time for this study
Key exclusion criteria (3 listed)
- employees absent due to long-term illness,
- employees absent due to parental leave
- employees absent due to long-term studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProMESProductivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement. Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback | Behavioural | Intervention group ProMES |
Primary outcome
Change in job strain (a measure of the balance between job demand and job control)
Time frame: baseline, 6-months, 12-months
QPSNordic questionnaire
9 secondary outcomes
Change in Effort-Reward Imbalance
Time frame: baseline, 6-months, 12-months
Change in experience of stress
Time frame: baseline, 6-months, 12-months
change in sleep difficulties
Time frame: baseline, 6-months, 12-months
change in Recovery
Time frame: baseline, 6-months, 12-months
change in depression
Time frame: baseline, 6-months, 12-months
change in Sick leave
Time frame: baseline, 6-months, 12-months
change in General health
Time frame: baseline, 6-months, 12-months
change in Productivity
Time frame: baseline, 6-months, 12-months
change in Exhaustion
Time frame: baseline, 6-months, 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Jensen, Professor principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing ProMES in people with Stress, Psychological, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in job strain (a measure of the balance between job demand and job control) (time frame: baseline, 6-months, 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.